NCT01961414

Treat and Extend Therapy Study Using Intravitreal Aflibercept for Patients Exited From Protocol VGFT-OD 0910

Treat and Extend Therapy Using Intravitreal Aflibercept (IAI) for Previously Treated Patients Exiting the Wet Age-related Macular Degeneration Extension Study (0910)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Palmetto Retina Center, LLC · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine if a "Treat and Extend" regimen (increasing the time between visits when the disease is stable and not getting worse) of aflibercept 2.0mg injections inside the eye for treating patients with Wet Age-related Macular Degeneration.

Detailed description

After exiting VGFT-OD 0910, patients will be enrolled into RANGE, a longterm extension trial evaluating the safety and efficacy of aflibercept IAI utilizing a "treat and extend" regimen. Using pre-specified re-treatment criteria, treatment intervals will be variable with dosing of the active treatment at least every 12 weeks.

Conditions

• Exudative Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Aflibercept	Patients will receive Aflibercept 2.0mg intravitreal injection at all scheduled study visits

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-03-01
• Completion: 2016-07-01
• First posted: 2013-10-11
• Last updated: 2015-10-30

Locations

6 sites across 1 country: United States